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NCT Number: NCT06349668

Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are:

* Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia? * Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications? * Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery? * Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery?

Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively.

QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary.

In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

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Key information

Conditions

Other Specified Disorders of Kidney and Ureter Benign Neoplasm of Ureter Benign Renal Neoplasm Calculus of Kidney and Ureter Congenital Ureteric Anomaly Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Nephrolithiasis Renal Cancer Ureter Cancer Ureteral Diseases Ureteral Neoplasms Ureteric Reflux Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urolithiasis Urologic Diseases Urologic Neoplasms Vesico-Ureteral Reflux

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Länssjukhuset i Kalmar, Kalmar, Sweden

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About this study

Please refer to CTIS

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
  • The patient gives oral and written informed consent after having received oral and writen information about the study

Exclusion criteria

  • The patient has a ASA-class of IV or above
  • The patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading or Swedish language abilities
  • The patient is a female who is pregnant or breastfeeding
  • The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and is not using highly-effective contraception with low user-dependency and cannot provide a negative pregnancy test
  • The patient is scheduled for emergency surgery
  • Research staff not available
  • Scheduled significant simultaneous surgery on another organ
  • The anesthesiologist in charge has planned spinal or epidural analgesia
  • The patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe obesity, severe scoliosis)
  • The patient has clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, myasthenia gravis, renail failure (eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher, severe cardiac arrythmias or insuffiency (NYHA IIIb or higher)
  • The patient has previously participated in the trial

Treatment and study plan

spinal analgesia with morphine and bupivacaine

Drug

single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery

Other names: morphine spinal

Lidocaine infusion

Drug

intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t after a bolus of 2 mg/kg (Ideal Body Weight if BMI > 22, otherwise ABW)

Other names: xylocaine iv

Primary outcomes

  1. QoR-15 score at postoperative day 1

    Time frame: First day after surgery

    Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing. The primary research hypothesis is that the reduction in QoR-15 from baseline before surgery to the first postoperative day (POD 1) is at least 8.0 points less in the morphine spinal group compared to the control group treated with intravenous lidocaine.

Secondary outcomes

  1. QoR-15 score preoperatively

    Time frame: Any time between inclusion and the night before surgery

    Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.

  2. QoR-15 score at postoperative day 7

    Time frame: Seventh day after surgery

    Quality of Recovery-15 score ranges from 0 to 150 with 0 reflecting zero wellbeing and 150 reflecting perfect wellbeing.

  3. Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU

    Time frame: 2 hrs after arrival to the PACU

    Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.

  4. Pain (NRS) on POD 1-3

    Time frame: First, second and third day after surgery

    Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.

  5. Pain (NRS) in rest and during motion at POD 7

    Time frame: Seventh day after surgery

    Numeric Rating Scale ranges from 0 to 10 with 0 reflecting absence of pain and 10 reflecting extreme pain.

  6. Time from arrival in the OR to start of surgery

    Time frame: Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs.

    Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs.

  7. Time from end of surgery until leaving the OR

    Time frame: Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs

    Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs

  8. Incidence of unplanned termination of the lidocaine infusion

    Time frame: Intraoperatively

    Incidence of unplanned termination of the lidocaine infusion

  9. Amount of remifentanil in patients given remifentanil

    Time frame: Intraoperatively

    Amount of remifentanil during anesthesia in patients given remifentanil expressed in mcg/kg/min as recorded on the anesthetic chart.

  10. Amount of intraoperative opioids in patients not receiving remifentanil

    Time frame: Intraoperatively

    Amount of intraoperative opioids in patients not receiving remifentanil expressed in mcg/kg/min morphine equivalents as recorded on the anesthetic chart.

  11. Length of stay at the PACU/ICU/HDU

    Time frame: Length of stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days

    Length of stay at the PACU/ICU/HDU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days

  12. Amount of opioids administred at the PACU/ICU/HDU during the first 24 hrs after end of surgery

    Time frame: During stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days

    Amount of opioids administered at the PACU/ICU/HDU expressed in mcg/kg morphine equivalents as recorded on the post-anesthetic chart.

  13. PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay

    Time frame: At 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay

    PONV requiring treatment at 0-6 hours and 6-24 hours

  14. "Time out-of-bed" on POD 1-3

    Time frame: First, second and third day after surgery

    "Time out-of-bed" on POD 1-3

  15. Amount of opioids administered during the first 24 hours at the PACU/ICU/HD and on the ward

    Time frame: During the first 24 hours at the PACU and on the ward

    Amount of opioids expressed in mcg/kg morphine equivalents administered during the first 24 hours at the PACU/ICU/HD and on the ward as recorded on the ward chart.

  16. First POD passing gases

    Time frame: From first until seventh day after surgery

    First POD passing gases

  17. First POD passing stool

    Time frame: From first until seventh day after surgery

    First POD passing stool

  18. Incidence of pruritus

    Time frame: From first until seventh day after surgery

    Incidence of pruritus

  19. Length of stay

    Time frame: From first until thirtieth day after surgery

    Length of stay in calendary days

  20. DAOH30

    Time frame: From first until thirtieth day after surgery

    Days Alive and Out of Hospital defined as the number of full calendary days where the patient is not admitted to a hospital and not deceased

  21. Postoperative complications untill POD 30

    Time frame: From first until thirtieth day after surgery

    Postoperative complications untill POD 30

  22. Requirement for opioids after discharge

    Time frame: From first until seventh day after surgery

    Y/N, based on a telephone interview

  23. Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia

    Time frame: From induction of anesthesia until 48 hours after induction of anesthesia

    Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours

  24. Intraoperative fluid balance

    Time frame: Intraoperatively

    Intraoperative fluid balance as recorded on the CRF in ml, defined by the estimated sum of administered fluids minus estimated bleeding, diuresis and other measurable losses.

  25. Time with low blood pressure during anesthesia

    Time frame: Intraoperatively

    Time with low blood pressure during anesthesia

  26. Lowest MAP within 10 minutes after induction of anesthesia

    Time frame: Within 10 minutes after induction of anesthesia

    Lowest MAP within 10 minutes after induction of anesthesia

  27. Highest MAP within 10 minutes of start of abdominal insufflation

    Time frame: Within 10 minutes of abdominal insufflation

    Highest MAP within 10 minutes of start of abdominal insufflation

  28. Fraction of patients needing norepinephrine within 15 minutes after start of abdominal insufflation

    Time frame: From anesthesia induction until 15 minutes after start of abdominal insufflation

    Fraction of patients needing norepinephrine within 15 minutes after start of abdominal insufflation

  29. Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of abdominal insufflation)

    Time frame: Intraoperatively (later than 15 minutes after start of abdominal insufflation)

    Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of abdominal insufflation)

  30. Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of abdominal insufflation

    Time frame: From anesthesia induction until 15 minutes after start of abdominal insufflation until end of anesthesiaon, up to 48 hours

    Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of abdominal insufflation

  31. Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of abdominal insufflation

    Time frame: From 15 minutes after start of abdominal insufflation until end of anesthesia (extubation), up to 48 hrs

    Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of abdominal insufflation

  32. Intraoperative Cardiac Index

    Time frame: Intraoperative

    Cardiac output corrected for Body Surface Area expressed in L/min/m2

  33. Intraoperative Stroke Volume Index

    Time frame: Intraoperative

    Stroke volume corrected for Body Surface Area expressed in mL/m2

  34. Intraoperative Cardiac Power Index

    Time frame: Intraoperative

    Cardiac Power Output corrected för Body Surface Area, expressed in Watt/m2, with higher values implying better cardiac performance.

  35. Intraoperative dPmx

    Time frame: Intraoperative

    Maximum increase in arterial pressure during a cardiac cycle, expressed in mmHg/second, with higher values implying better cardiac contractility.

  36. Intraoperative Pulse Pressure Variation

    Time frame: Intraoperative

    Determined as the ratio of the difference between the maximal and minimal values of pulse pressure over the mean of these two values and expressed as a percentage

  37. Intraoperative Stroke Volume Variation

    Time frame: Intraoperative

    Determined as the ratio of the difference between the maximal and minimal values of stroke volume over the mean of these two values and expressed as a percentage

  38. Intraoperative dynamic arterial elastance

    Time frame: Intraoperative

    Determined as Pulse Pressure Variation divided by Stroke Volume Variation

  39. Intraoperative Systemic Vascular Resistance Index

    Time frame: Intraoperative

    Intraoperative Systemic Vascular Resistance corrected for Body Surface Area

  40. Intraoperative heart rate

    Time frame: Intraoperative

    Intraoperative heart rate

  41. Biochemical markers of inflammation

    Time frame: Day of surgery and first and third day after surgery.

    To be specified later during the study (samples are stored for later analysis)

Study contacts

Contact information is provided by the study sponsor or research team.

Hans Bahlmann, MD PhD

CONTACT

[email protected]

+46739312281

Martin Holmberg, MD

CONTACT

[email protected]

+46101033932

Sponsors and collaborators

Lead sponsor

Hans Bahlmann

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Acronym: SMILe

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 5, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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